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Brite Gold XH alloy intended to be used for onlays, % crowns, crowns and short span bridges PFM crowns

Bright Gold

I am sorry, but based on the provided text, I cannot provide a description of the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a dental alloy named "Bright Gold xh" (and later corrected to "Brite Gold XH").

The letter states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the device has been found to be as safe and effective as a device already on the market, but it does not include details about specific performance acceptance criteria or a study demonstrating that the device meets those criteria.

The document primarily focuses on:

• The device name and regulation details.
• The FDA's finding of substantial equivalence.
• Regulatory requirements and responsibilities for the manufacturer.
• The intended indications for use (onlays, ¾ crowns, crowns, short span bridges, PFM crowns).

It does not contain the specific information requested in your prompt regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance of a test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for the training set was established.

These kinds of details would typically be found in the premarket notification submission itself (which is not provided here) or in a separate study report, not in the FDA's clearance letter.

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Simidur Superior is a palladium - silver ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients.

It is intended for manufacturing

• Crowns
• Short span bridges
• Long span bridges
• Removable partials

and can be used for

• Telescopic and milling work
  Simidur Superior can be veneered with suitable dental ceramics as well as with dentalcomposites.

SIMIDUR SUPERIOR is a palladium-silver ceramic alloy with high contents of precious metals (87,0%), intended for dental technicians to fabricate dental restorations.

It has an indication for use which ranges from single crowns up to long span bridges with two or more pontics. In addition, it can be used for removable partials as well as for telescopic and milling work.

SIMIDUR SUPERIOR is highly corrosion resistant and has aan excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.

SIMIDUR SUPERIOR can be veneered with suitable dental ceramics and with dental composites.

I am unable to extract specific acceptance criteria for the device performance from the provided text. The document is a 510(k) summary for a dental alloy, Simidur Superior, and primarily focuses on its substantial equivalence to a predicate device and its compliance with general regulations and standards.

The text states:

• "SIMIDUR SUPERIOR is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices."

However, it does not provide:

• A table of specific acceptance criteria (e.g., minimum tensile strength, maximum corrosion rate, specific biocompatibility test results with acceptance thresholds).
• Any details of a specific study or test results that "prove the device meets the acceptance criteria." The mention of compliance to ISO 9693 implies testing was done, but the results and methodologies are not described in this document.

Therefore, I cannot provide the requested table or details about a study, sample sizes, ground truth, experts, adjudication, or MRMC/standalone studies. This 510(k) summary is a declaration of compliance rather than a detailed report of performance testing.

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Precious Alloy for use in Crown and Bridge Dental Restorations.

Stengold 1 is a Yellow Crown and Bridge Alloy.

The provided FDA 510(k) summary for the "Sterngold 1" dental alloy does not contain the detailed information typically found in a study demonstrating device performance against specific acceptance criteria for AI/imaging devices.

This document describes a "Special 510(k): Abbreviated 510(k)" for a dental alloy, not an AI or imaging device. The regulatory pathway for this type of device relies on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than conducting performance studies with detailed acceptance criteria as would be expected for a diagnostic AI tool.

Therefore, many of the requested categories are not applicable to this submission.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The submission is for a dental alloy, which relies on demonstrating conformity with FDA guidance for dental alloys and comparison to predicate devices, rather than performance metrics like sensitivity, specificity, or image quality against acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. There is no "test set" in the context of an AI/imaging device described. The submission focuses on the material properties and intended use of a dental alloy.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. Ground truth establishment by experts for a test set is not relevant for a dental alloy submission.

4. Adjudication Method for the Test Set:

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

Not applicable. This is not an AI-assisted device.

6. If a Standalone (Algorithm Only) Performance Study Was Done:

Not applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used:

Not applicable. The "ground truth" for a dental alloy would relate to its material properties, biocompatibility, and mechanical performance, which are assessed against recognized standards and predicate device data, not through expert consensus on diagnostic images or pathology.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not a machine learning device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary of the K022252 Submission for Sterngold 1 Dental Alloy:

The K022252 submission for Sterngold 1 is an Abbreviated 510(k) for a "Yellow Crown and Bridge Alloy." This pathway is used to demonstrate substantial equivalence to legally marketed predicate devices by conforming to recognized standards and guidance documents.

• Acceptance Criteria (Implicit): Conformance to FDA's "Guidance Document for the Preparation of Premarket Notifications [510(k)'s] for Dental Alloys" and equivalence in material properties and safety/effectiveness to predicate devices (Harmony Medium, Monogram II).
• Study That Proves the Device Meets Acceptance Criteria: The submission itself, by providing information to demonstrate conformity with the FDA's guidance document for dental alloys, serves as the "study." This typically involves presenting data on material composition, mechanical properties, and biocompatibility, as well as a comparison to the predicate devices. The conclusion states: "Based on the indications for use, technological characteristics, and comparison to predicate devices, Sterngold 1 has been shown to be safe and effective for its intended use."

The FDA's review resulted in a determination of substantial equivalence, allowing the device to be marketed. This regulatory pathway does not necessitate the types of performance studies or ground truth establishment described in the prompt, which are more relevant for diagnostic devices, particularly those incorporating AI.

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Eco E4 is a silver-palladium casting alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Inlays/onlays - Crowns - Short span bridges - Long span bridges Eco E4 can be veneered with suitable dental composites.

Eco E4 is a high strength silver-palladium casting alloy, intended for dental technicians to fabricate dental restorations. It consists of silver, palladium and gold (93,5%) as well as of copper and zinc. Eco E4 has an indication for use which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics. It complies with the international standard ISO 8891 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.

The provided document is a 510(k) premarket notification for a dental alloy, Eco E4. It outlines the device description, its intended use, and its equivalence to a predicate device. The document does not contain any information about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic accuracy studies.

Instead, it focuses on the materials science and regulatory compliance aspects of a physical product (dental alloy). Therefore, I cannot extract the requested information based on the input document.

The document indicates that Eco E4 is a "high strength silver-palladium casting alloy" for dental restorations and that it "complies with the international standard ISO 8891 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." This implies that the 'acceptance criteria' for this device would relate to its material properties and manufacturing standards, not to diagnostic accuracy.

No information is available in the provided text regarding:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI/ML.
2. Sample size used for a test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm only) performance study.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

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Precious alloy for use in Crown and Bridge dental restorations.

Sterngold 66 is a White Crown and Bridge Alloy.

This is a traditional 510(k) submission for a dental alloy, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML device is not available in the provided documents.

The submission focuses on demonstrating substantial equivalence to predicate dental alloys based on material properties and intended use. The "Safety and Performance" section states:

"This submission is a Special 510(k): Abbreviated 510(k) as described in FDA's guidance document entitled 'The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.' In support of this 510(k), Sterngold has provided information to demonstrate conformity with FDA's guidance document entitled Guidance Document for the Preparation of Premarket Notifications [510(k) s] for Dental Alloys)."

This indicates that the "acceptance criteria" for a dental alloy would relate to its physical, chemical, and biological properties (e.g., biocompatibility, corrosion resistance, mechanical strength) as defined in relevant consensus standards or FDA guidance documents for dental alloys, rather than performance metrics for an AI/ML algorithm. The "study" would involve material testing to show these properties meet established benchmarks or are comparable to predicate devices.

Since the provided information is for a physical medical device (dental alloy), AI/ML-specific questions like sample size for test/training sets, data provenance, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable.

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Simidur S2 is a palladium-base ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Crowns, Short span bridges, Long span bridges, Removable partials and can be used for - Telescopic and milling work. Simidur S2 can be veneered with suitable dental ceramics as well as with dentalcomposites.

Simidur S2 is a palladium-base ceramic alloy with a high content of noble metals (81% ), intended for dental technicians to fabricate dental restorations. lt has an indication which ranges from single crowns up to long span bridges with two it has an indication which farges wortials. It is free of silver and suitable for telescopic and milling work. Simidur S2 is highly corrosion resistant and has an excellent biocompatibility. It fully Simidal U2 is highly ochooled ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. Simidur S2 can be veneered with suitable dental ceramics and with dental composites.

This document does not contain information about acceptance criteria or a study proving that the device meets those criteria. The provided text is a 510(k) summary for a dental alloy, Simidur S2, and the associated FDA clearance letter. It focuses on the device description, its indications for use, and its substantial equivalence to a legally marketed predicate device (Spartan Plus).

Therefore, I cannot populate the requested table or answer the specific questions about "acceptance criteria and the study that proves the device meets the acceptance criteria," as this information is not present in the provided text.

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Simidur KF plus is a palladium-base ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Crowns, Short span bridges, Long span bridges, Removable partials and can be used for Telescopic and milling work. Simidur KF plus can be veneered with suitable dental ceramics as well as with dentalcomposites.

Simidur KF plus is a palladium-base ceramic alloy (79,7% Palladium), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from single crowns up to long span bridges with two or more pontics and to removable partials. It is free of copper and suitable for telescopic and milling work. Simidur KF plus is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. Simidur KF plus can be veneered with suitable dental ceramics and with dental composites.

The provided text describes a Premarket Notification 510(k) for a dental alloy named "Simidur KF plus." This document serves to establish substantial equivalence to a legally marketed predicate device, not to present a study demonstrating the device meets a set of acceptance criteria. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document, as it is not a study report.

The document primarily focuses on:

• Device Description: Simidur KF plus is a palladium-base ceramic alloy (79.7% Palladium) for fabricating dental restorations (crowns, bridges, partials, telescopic and milling work).
• Intended Use: To be used by dental technicians to fabricate dental appliances for patients.
• Compliance: States it complies with international standard ISO 9693 and European directive 93/42/ECC concerning medical devices for corrosion resistance and biocompatibility.
• Substantial Equivalence: It is deemed substantially equivalent to the predicate device "Argebond 80" (K 913704).

Therefore, it is impossible to complete the requested table and answer the specific questions about acceptance criteria and a detailed study design from the given text. This document is a regulatory submission for market clearance based on equivalence, not a scientific publication detailing a performance study against specific acceptance criteria.

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Simidur S1S is a palladium-base ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Crowns, Short span bridges, Long span bridges, Removable partials and can be used for - Telescopic and milling work. Simidur S1S can be veneered with suitable dental ceramics as well as with dentalcomposites.

Simidur S1S is a palladium-base ceramic alloy (56,0% Palladium), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from single crowns up to long span bridges with two or more pontics and to removable partials. It is free of copper and suitable for telescopic and milling work. Simidur S1S is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. Simidur S1S can be veneered with suitable dental ceramics and with dental composites.

The provided text describes a submission for a dental alloy, Simidur S1S, to the FDA for 510(k) premarket notification. The document states that the device "fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." However, it does not contain the detailed methodology and results of a study as typically required to demonstrate that a medical device meets specific acceptance criteria in the manner requested. Specifically, it lacks information regarding clinical studies, performance metrics, sample sizes, ground truth establishment, or expert involvement in a medical device testing context.

Thus, I cannot provide the requested table or describe a study in the detailed format requested based on the given information. The document focuses on regulatory approval based on "substantial equivalence" to a predicate device (Argelite 58P, K891320), rather than on a new clinical performance study.

Here's what can be extracted, aligning with the spirit of the request but acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• This information is not provided in the document. The submission relies on "substantial equivalence" to a predicate device and compliance with standards, rather than a clinical trial with a defined test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided. The document does not describe a clinical study or expert-adjudicated test set.

4. Adjudication method for the test set:

• This information is not provided. No adjudication method is mentioned as there isn't a described test set requiring one.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study was not conducted or described. This type of study is relevant for AI-powered diagnostic devices, which is not what Simidur S1S is.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• No, a standalone algorithm performance study was not conducted or described. This device is a physical dental alloy, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this device's performance is established by compliance with international standards (ISO 9693) and European directives (93/42/ECC), as well as by demonstration of substantial equivalence to an already marketed device (Argelite 58P). The document does not specify a clinical "ground truth" derived from patient outcomes or pathology in the context of a new study for this submission.

8. The sample size for the training set:

• This information is not applicable as Simidur S1S is a material, not an AI model, and therefore does not have a "training set."

9. How the ground truth for the training set was established:

• This information is not applicable for the same reason as point 8.

In summary, the provided FDA 510(k) summary is for a dental material (alloy) and discusses its compliance with established material standards and equivalence to a predicate device, rather than presenting a performance study with detailed clinical acceptance criteria, test sets, or expert evaluations typically associated with diagnostic or AI-driven medical devices.

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d-Sign 84 is intended to be used with conventional feldpathic porcelains. Also a-olgh 04 intended to be assa mas, conus crowns, conus crowns, posts, attachments, short and long span bridges, and PFM crowns.

Not Found

The provided text is a 510(k) premarket notification approval letter for a dental alloy, D.SIGN 84. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device, a diagnostic device, or any device that would have measurable performance characteristics like sensitivity, specificity, or accuracy against ground truth.

Therefore, I cannot extract the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, not on specific performance metrics or clinical study results as you would expect for the type of questions asked.

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d.SIGN 59 alloy intended to be used for onlay, ¾ crows, telescope crowns, conus crowns, posts, short and long span bridges, PFM crowns.

d.SIGN 59 alloy

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a dental alloy named "d.Sign 59," confirming its substantial equivalence to a legally marketed predicate device.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance
2. Sample size and data provenance for a test set
3. Number and qualifications of experts for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study details
6. Standalone performance details
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

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